Tag: GSK

(you can download the evidence from the publicly available site- Pacer- or from here – from Exhibit 25)Exhibit 25

There’s a case brewing in the US (that I have been following attentively), which I think could be one of the most scandalous cover-ups in Big Pharma history. The documents I am about to reveal (all publicly available and downloadable through the Pacer Website) are absolutely damning for GlaxoSmithKline. However the public must be warned because lives are at risk.

The case basically involves a whistle-blower called Thomas Reilly who has taken a wrongful termination case against GSK. Reilly was head of GSK’s Global IT systems (the computer systems that run GSK’s product manufacturing globally). In 2015- When Reilly tried to warn the CEO at the time- Andrew Witty- that there are serious problems, Witty seemed to brush him off (see excerpts below). If Thomas Reilly’s allegations of serious problems with GSK’s manufacturing are true (and I have no reason to believe that they are untrue, particularly considering the dozens of recalls – that I have documented- of their various products- over the years) then this essentially means that no GSK product can be trusted to be safe.

It also means that many millions of people globally, are at risk, of ingesting either a defective, contaminated, or just shoddily produced GSK product at any time. We are all at risk here, because we all need drugs/treatments from time to time, due to illness or injury etc, and GSK are one of the biggest suppliers of Pharmaceuticals/consumer health products in the world. Even those who work for GSK are at risk (they take meds too), and their family/friends etc are at risk also- because due to their dodgy manufacturing/defunct IT processes within their global supply chain- we simply do not know if a GSK product is ever safe or not (for a long, but not extensive, list – of GSK recalls- see this link)

And see how GSK’s Andrew Witty (CEO at the time- 2005) glibly and nonchalantly dismissed IT Expert (and GSK employee at the time) Thomas Reilly’s serious concerns about GSK’s global manufacturing/IT systems.

Bear in mind, that GSK have had many criminal investigations against them over the past decades, and that they have previously been fined (as a felon) in a 3 Billion lawsuit – instigated by the Department of Justice and Whistle-blower Greg Thorpe in 2012.

They were also fined in China in 2014 for similar damning corruption and fraud allegations.

GSK has a long history of breaking ethics/morals and harming consumers (see the Seroxat and Avandia debacles for a taste of how bad GSK treat users of their products).

We have no reason to trust them in any sense whatsoever. They have given us absolutely no reason to trust them- ever.

how many cases like this of bad batches of drugs/products slip through oversight and go unreported? how bad are GSK’s manufacturing processes? and how many people get harmed from using GSK products without even realizing it?

(if any journalists/whistle-blowers are interested in this scandal – please contact me by email)

I will cover more of these publicly available and downloadable documents over the coming days.

This is just the beginning of another GSK scandal; a scandal that illustrates how everyone (across the globe)is at risk of harm from a dodgy GSK product because of their defunct manufacturing cover up.

GSK is no stranger to scandal, and no stranger to harming people with dodgy meds, but the sheer scale of harm to consumers from this current massive cover-up is staggering.

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GSK Hides Dangerous Side-effects of Epilepsy Drug, Lamictal

GSK Hides Dangerous Side-effects of Epilepsy Drug, Lamictal

While we all know that any drug comes with side-effects, it’s critical that drug companies and foundations tell the public the truth about those side-effects.

In this Video:

Learn how drug giant GlaxoSmithKline lied to the FDA and withheld critical information tying their seizure medication Lamictal to a devastating condition known as Steven Johnson Syndrome (SJS) and even toxic epidermal necrolysis (TEN).

How their Drug increases suicide and suicidality by more than 3 fold.

How the Epilepsy Foundation fails to mention the corruption/fraud behind this drug and the real risks of life altering permanent side-effects.

Watch as Dr. Dale breaks down the problems with Big Pharma fraud and The Epilepsy Foundation’s misinformation regarding the true risk of Lamictal.

It is my hope that as a community and nation we can drive real change and end corruption within medicine.

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I reported on GSK’s involvement in the Tuam (Irish) baby trials several years ago on this blog, so it’s good to see that others have taken up the baton and now there is a lot online about these very dodgy trials. Great research from whoever wrote the article below and an interesting slant also when comparing GSK’s past trials on Irish orphans with its not so long ago- Study 329 Paxil (Seroxat) Trial-

“….In Study 329 you were informed that participation in the trial would not lead to any different treatment from standard clinical care. Well standard clinical care for the use of imipramine in adults at that time would have been to use doses of around 150 mg or less. In their adult trials running at the same time, GSK were using a 150 mg dose. But in Study 329, the protocol from the get go mandated pushing every child who got imipramine up to 300 mg if possible. It’s difficult to see any rationale for this other than by making imipramine look so toxic, Paxil might look good by contrast….”

Illegal Drug Experiments

The trial was published in the ‘British Medical Journal’ in 1962. The final paragraph of the Report reads;-“We are indebted to the medical officers in charge of the children’s homes. . . for permission to carry out this investigation on infants under their care.”Dr Saunders, happy with the trials wrote “the results confirm the results obtained by Wellcome with guinea pigs”. According to a 1932 medical journal, Wellcome lab workers who prepared the vaccine for diphtheria had a “complete lack of experience of its use with human beings”

“A spokesman for GSK (GlaxoSmithKline Pharmaceutical Company )– formerly Wellcome – said: –‘The activities that have been described to us date back over 70 years and, if true, are clearly very distressing.”“Some of the original batches of the alum-toxoid vaccine, which comprised of 9 per cent aluminium, caused severe reaction like fatal abscesses and hard lumps at the injection site.”

VACCINE TRIALS;-The letter below deals with Vaccine Trials carried out on babies and children in institutional setting in Ireland during the 1960’s and 1970’s.Commission to Inquire into Child Abuse (C.I.C.A)
Vaccine Trials InquiryReport on 3 Clinical Trials involving babies and children in institutional settings 1960/’61, 1970 and 1973
​Over 2,700 children living in Mother and Baby Home and Orphanages in the 1960s and 70s were used as Human Guinea Pigs in illegal Medical Trials. Ireland had no laws pertaining to medical testing until 1987.Doctors and Pharma​So who is now entering children into clinical trials like Study 329 – GlaxoSmithKline’s (GSK) famous trial of Paxil (Seroxat – paroxetine) compared to imipramine and placebo in adolescents who were supposedly depressed? Is the pharmaceutical industry wonderfully more ethical and concerned about children than the Catholic Church was? Does industry profit from this? Are the doctors reimbursed for each child entered? (Likely around $5000 per child).

Unlike the 1960s, there is of course informed consent now. In Study 329 you were informed that participation in the trial would not lead to any different treatment from standard clinical care. Well standard clinical care for the use of imipramine in adults at that time would have been to use doses of around 150 mg or less. In their adult trials running at the same time, GSK were using a 150 mg dose. But in Study 329, the protocol from the get go mandated pushing every child who got imipramine up to 300 mg if possible. It’s difficult to see any rationale for this other than by making imipramine look so toxic, Paxil might look good by contrast.

Our skin is the parchment upon which our identity is written, class, race, ethnicity and gender are read upon the human surface of our skin. The same applies to the stealing of a baby, which tears away that child’s identity and leaves a blank slate upon which abuse, punishment, sanctity or monstrosity can be committed upon and etched into both the mother and child’s mind, illegal adoptions, strips away the means by which children see themselves or are viewed by others. Really a stolen life of slavery, a distraught mother, an abused child, endless search, eternal hunt for the truth and the real mother. The Irish Catholic Church authorities incarcerated a large number of children in Industrial Schools and transit Orphanages throughout Ireland. Physicians and medical researchers for the Drug Companies used a number of babies children, including their mothers, in the Irish Orphanages for medical experiments that often resulted in the deaths of both the children and their mothers. The Irish Catholic Church authorities deployed helpless adolescents, particularly younger women, as forced labor in the Magdalene Laundries, where many died because of the monstrous work conditions, the Irish Catholic Church authorities held other children under appalling conditions in both Industrial Schools and transit Orphanages.

The term “euthanasia” means literally “good death” It usually refers to the inducement of a painless death, many of the Down Syndrome and other chronically and terminally ill children and babies who would otherwise suffer in the many Convents and Mother and Baby Homes, were put to death, an euthanasia program which was indirectly sanctioned by The Irish Catholic Church authorities, this clandestine murder program was carried out in the many Mother and Baby Homes and Convents throughout Ireland, through illegal medical experiments. This “euthanasia” program targeted, for systematic killing, mentally and physically disabled babies and healthy children living in institutional settings throughout Ireland, run by the Irish Catholic Church. What sort of religion that would allow orphan children in their orphanages to be illegally experimented on for money and then the same drug company and the Irish Catholic Church watches the vulnerable children die. The Nuns that ran the orphanages than sold the children’s tiny battered bodies back to the same drug company that exterminated the orphan children in the first place. The Irish Catholic Church didn’t alleviate the suffering among the women and children in its care, instead the Irish Catholic Church’s indifference, and open complicity in the rape torture and extermination of children and women in its pastoral care.

Both St Philomena’s Home in Stillorgan in Dublin, and St. Patrick’s, Mother and Baby Home on the Navan Road, Dublin were used as experimental centers by the drug companies in Ireland to test out new and upcoming commercial medical drugs, with the approval of the Catholic Church and The Irish Government. These were the Vaccine Trials that were carried out secretly, on babies, children in institutional settings in Ireland during the 1940s, 50s, 60s, and 70s.

According to a British Medical Journal, the Burroughs Wellcome Company medical laboratory technicians who prepared and gave the vaccine for diphtheria and other untried medical drugs to the orphan children had a complete lack of experience and training of its uses with human beings, especially babies and children. The initial trials were carried out on hundreds of babies and children from the many Mother and Baby Homes and Orphanages throughout Ireland, from the 1920a though the early 1970s. In the case of diphtheria vaccine drug from the original batches the alum-toxoid vaccine level, at that time, the diphtheria vaccine dosage which comprised of over 9 per cent aluminium, caused severe reaction like fatal abscesses and hard lumps at the injection site., like intense pain, swelling and redness, causing fatal skin lesions, which resulted in skin lesions and the drugs rash that the nuns knew nothing about, started to appear on the babies and children in their care.

The fatal skin lesions were at the time different cancers, life-threatening complications which caused toxic shock syndrome, which was a potentially fatal illness caused by a bacterial toxin, the causative bacteria Staphylococcus aureus, toxic epidermal necrolysis, pemphigus vulgaris, milder side effects, included raving fever, shivers, constant fatigue, severe headache, intense vomiting, multiple muscle spasms and enflamed joints. The severity of the many of the side-effects which were covered up by both the drug company and the Nuns at the time resulted in the death of the babies and children in the pastoral care of the Nuns. These Vaccine Experiments carried out were carried out on thousands of defenceless Babies, Children and new mothers in the many Mother and Baby Homes and Children’s Orphanages throughout Ireland. After all, here were a ready group of helpless children who had no Parents or people to complain to. Some of these experiments, took place in St. Patrick’s Mother and Baby Home, Dublin, where I was born and St Philomena’s Home in Stillorgan in Dublin, on children as young as six months old. I often ask, have we forgotten God?

The vaccines used were all manufactured by the same company, Burroughs Wellcome, and then if and when many of the Babies and Children died, the good Nuns sold their bodies to the Department of Medical Microbiology, University College Dublin and Trinity College, Medical Centre and even to the Drug Companies. The asking price was £1,000 for a dead body of a Baby or child, a huge sum of money at the time. The Catholic Church in Ireland made hundreds of thousands of pounds in an exclusive deal with the drug Companies for access to the Babies and Children in the orphanages and Mother and Baby Home in Ireland.

Polio is an infectious disease caused by a virus that lives in the throat and intestinal tract. Polio is actually spread via faces or oral route. It is most often spread through person-to-person contact with the stool of an infected person and may also be spread through oral, nasal secretions. Polio used to be very common in Ireland and caused severe illness in thousands of children before the introduction of polio vaccine in 1957. Sanitation is preeminent in containing polio outbreaks. Live poliovirus vaccine caused outbreaks of Polio, in The Mother and Baby Homes, due to the live Poliovirus in the vaccine. Injections of live Polio Vaccine increased the risk of polio in children. The Polio Vaccine was injected, live, into the institutionalised children, in many Mother and Baby Homes, in Ireland. The Drug Companies introduced the Polio Vaccine experiments, into Mother and Baby Homes, in the late 1940’s.

The scandalous, experimental drug unit from the Wellcome Trust took great pride in naming, the drug experiments the ‘Orphan Bastards’ and didn’t hold back with any drug or technique, on the vulnerable orphan children, multiple untried medical drugs were used in these experiments by this elite unit from the Wellcome Trust. This was not the first time for drug experiments on Orphan Children, from the Wellcome Trust. The Wellcome Trust also has a long history in staunch Catholic South America countries, parts of Asia and poorer Catholic countries throughout Africa, up to the 2006.

At first, the Nuns in Mother and Baby Homes were emboldened to neglect the children and their mothers in their care, thus, the children and their mothers die of starvation and curable diseases, because the Nuns wouldn’t buy medicines or provide proper food. Later, groups of drug company medics came with their cheque book visiting the Mother and Baby Homes and decided which child would die, and which woman. The Nuns at the Mother and Baby Homes viewed the life of the unwed women and their children as worthless in the eyes of God, “life unworthy of life” the Nuns also viewed the children and unwed mothers as a financial burden on the Irish state and particularly the Irish Catholic Church.
In reality, the Mother and Baby Homes were children’s killing wards where, specially recruited medical staff from the drug companies exterminated the new babies, their mothers by either a lethal experimental overdose of medication or by induced starvation.

The Mother and Baby Homes were willing to participate and help in the illegal drug experiments on both healthy and stricken orphan children without proper safeguards or consent, consent which wasn’t asked for or needed as the Nuns through the Irish Catholic Church secretly approved the drug experiments for cash payments. The Orphan Children in The Mother and Baby Homes were used as “guinea pigs” at most Catholic run orphanages. Consent and safeguards where not required or called for, as the drug experiments were on Orphan Children, approved by the powerful Irish Catholic Church with sections of the cowardly Irish Government Officials. All the Mother and Baby Homes records were kept secret and later destroyed on instructions, after a secret meeting of the Irish Catholic Bishops of Ireland in 2005 in Dublin, to protect the reputation of the then battered Irish Catholic Church.

Let there be no mistake, many of these vulnerable Orphan Children died as a direct result of these Illegal Drug Experiments in the many Mother and Baby Homes throughout Ireland. Surreptitious inoculation was used on these vulnerable Orphan Children. Once the Orphan Child was infected, by the drug experiments the child was given diphtheria or penicillin or other untried medical drugs to see if it the drug worked, the illegal medical drug was given in different dosage to the child from strong to weak to see the desire results and watch the vulnerable orphan children struggle to live or die. In some cases no drug was given, as the child would then struggle with the bad drug given to the child, in the first place, as the Drug Unit watched dispassionately at the struggling child, recording the child’s every dying moment. Over 2,500 Orphan Children were exterminated this way.

Vulnerable Orphan Children, have often been the unwilling objects of these evil experiments. From the 1940s to 1970s, by The Wellcome Trust, later known as GlaxoSmithKline, conducted these experiments on the vulnerable Orphan Children with the approval of the Irish Catholic Church. The Orphan Children were injected with a variety of untested medical drugs, long after the experiments ended, vulnerable Orphan Children that survived, continued to suffer from the side effects of the illegal drug experiments.

The medical doctors who done the experiments were apparently very enthusiastic about the experiments on the vulnerable Orphan Children, it was written by one of the lead doctors, at the time, and he was quoted as saying, “Fantastic results, for this invaluable research, we have to thank the Irish Catholic Church for the unfretted use of the Orphan Bastards.
The known side effects on the Children that survived were the Orphan Children had volcanic eruptions of skin inflammation, rashes and angry scars, cancers, stunt growth, severe acne outbreaks, cancerous cysts, pustular psoriasis, on the face, neck armpits and around the chest area and the back, and groin areas, with itching and violent irritations of the skin. Many died a few years after the illegal drug experiments due to unidentified malignant tumours. Carcinoma cancers that grow out of control, these cancerous tumours invaded nearby tissues and spread to other parts of the body as a direct result of the illegal drug experiments on them as Orphan Children.

As a direct result of the illegal drug experiments carried out in the Mother and Baby Homes, many of the surviving Orphan Children’s cells were damaged and altered and the cells began to grow uncontrollably, becoming malignant. Of course these Orphan Children later as adults had no medical records for future doctors to look at and assist them in their treatment, their medical records from the Catholic Orphanages were sealed and later, all their medical histories from the Mother and Baby Homes were destroyed, on the direct orders of the Irish Catholic Church. Their future doctors didn’t know what they were dealing with and hence the survivors went to their lonely graves never knowing what really happened to them as Orphan Children in the Mother and Baby Homes.

I was one of the experimental babies and I was given live Polio Vaccine in 1955; I have a medical document in my name to support this. The Medical Documents read Polio Vaccine; – 1st. Injection 18th. June 1955 and 2nd. Injection 17th. July 1955, I would have been 13th. months old at the time, I was born on 27th. May. 1954, so not really 13th. months, further the document reads;- Positive Post Vaccine Test.

I was in the early group of babies that got vaccinated in St. Patrick’s Mother and Baby Home Dublin. Medical miracles are complicated, but Catholic Church Miracles are never complicated, Catholic Church miracles are downright fraud, but if the miracles involve money, and if it is a great miracle, the Catholic Church will hijack that miracle to make money. There will be no testing or verification by scientists, only the Catholic Church can do that itself. It is a poor Roman Catholic Church in Europe that does not boast several relics of Saints and wooden crosses.

Although the scientific method of hypothesis formulation, testing, and verification is straightforward, even the most spectacular achievements involve complicated issues and tough choices. The doctors and scientists who raced toward effective polio vaccines tested their handy work on institutionalised Orphan Children prior to 1955, in the orphanages of Ireland, when the Irish Government announced that polio vaccines was to come to Ireland in 1958, In The Irish Republic. Many Mother and Baby Homes in Ireland, had already participated with the Drug Companies, in secret for years before the Irish Government’s announcement, in 1958. The Nuns and the Irish Catholic Church already had their thirty pieces of silver and with no remorse, gladly accepted the cash at the expense of the extermination of defenceless Orphan Children in its care.

One of the first batches of polio vaccines tested wholesale was in Philadelphia, Pennsylvania, in America, on hundreds of children. Over 200 of the children died within a few weeks, the dosage was mixed wrong with too much aluminium. The doctors remixed the next batch of polio vaccines and again tested the new batch on orphans in the Mother and Baby Homes in Ireland. As a result more children died in the Mother and Baby Homes in Ireland, and many were left crippled for life, a few of the children struggled for a few more years and died.

In addition over 100,000 Rhesus monkeys died as well as the institutionalised children. Many healthy children given the polio vaccines were disabled for life. They were a visible, painful reminder to society of the enormous toll this disease took on young lives. The doctors and scientists believed they were serving the greater good of society and of science. The Catholic Church believed they were serving the great good and wealth of The Catholic Church.

The Drug Company, The Wellcome Trust, also carried out Another Drug Company experiment that went wrong in many Mother and Baby Homes in Ireland. The Vaccine in question was for the Vaccine for Diphtheria, like polio Vaccines, The so called Wellcome Doctors, had a “complete lack of experience of its use within human beings, Wellcome lab workers who prepared the formula, got the formula wrong, and as a result, hundreds of Orphan Children died.

Most of the orphan babies and children were exposed to toxic high levels of aluminium salts posing very significant health risks including death to the babies and children. Many of the same high toxic vaccines were also given to pregnant women, which in addition to these animal cells and associated genetic material also had high level of aluminium salt in them. A few foetus expelled from the mother’s body while other babies died after receiving the experimental vaccines or untried combinations of vaccines numbering in the single digits. In some cases a few babies born, surveyed for six or seven months and then died in their sleep, after receiving different experimental vaccines.

Babies and premature babies had to deal with this overloading of their kidney functions, which failed, high level aluminium salts promotes cellular death, that’s a fact. We also know of a direct link between high levels of aluminium salts and Alzheimer’s disease later in life. Aluminium is able to travel into places in your body where it can do significant harm, and your brain is one of the organs that’s most sensitive to it, adverse effects of aluminium skews your immune system.

Multiple vaccines, or several shots of vaccines administered all at once, by the drug companies were responsible also for a large percentage of serious adverse vaccine reactions in the Orphan Children that were experimented on, including myself, in the Mother and Baby Homes. As is now well known in the scientific world today, there are no valid scientific studies to support the safety of given several vaccines all at the same time to children. The vaccines that were administered to Orphan Children, simultaneously for the convenience of both the drug companies and the Mother and Baby Homes was never about safety.

Some of the children in the Mother and Baby Homes had partial seizures like staring, pupils not contracting when a flashlight was shone by the doctors into their eyes, non-responsive; some children fell asleep with fingers of both their hands twitching rhythmically. I, myself was hospitalised one year after my birth, because of my violent reaction to some experimental drugs pumped into my tiny body, and rushed to another emergency hospital in Dublin, because of the serious adverse reaction to the vaccine I was injected with by the drug company.​

I recovered. I had a desire to survive, but I couldn’t walk till I was four. Other Orphan Children had high fever, vomiting, and diarrhoea, a few Orphan Children died and their battered and bruised bodies sold back to the drug company or sold to medical Colleges in Dublin, by the heartless Nuns for profit.

Some of the Orphan Children had from three to six diseases injected together directly into their tiny bodies with one multiple shot, while the drug company doctor looked on, to see what would happen. The multiple shots were measles, mumps, rubella, diphtheria, pertussis, tetanus, polio, and because of the drug experiments some of the children developed asthma, celiac disease, and autism and other complications. A few of the children had chronic vomiting and diarrhoea that were attributable directly to his celiac disease vomiting every day, some of the orphan children couldn’t speak, because they lost the temporary use of their voices. Other orphan children had red eyes at the time of their immunisations, many were very ill for days or weeks afterwards.

A few of the Orphan Children also had serious reaction to their very first set of drug shots. The Drug Company Doctors observed this correlation, and then gave a second set of experimental drug shots, to the hapless children and watched the poor wretched children’s new reactions again. The Drug Company Doctors clinically took reams of notes as they observed the distressed and floundering Orphan Children, the Nuns of the Mother and Baby Homes were to busy eating free cakes and drinking drug company tea to ask any questions and really didn’t care, after all, all the drug company staff were dressed as doctors and nurses.

Again the Drug Company Doctors watched life-threatening reactions by the now floundering Orphan Children to his second set of experimental drug shots and proceeded to administer again to the same now very distraught children, a third set of multiple drug shots. In reality the Mother and Baby Homes relinquish all responsibility for their babies welfare. The Drug company Doctors just observed as some children struggled to breath, and never intervened as children as young as four died in their own vomit and tears.

The Drug Company Doctors just took notes, The Nuns prayed as they sold the dead children to The Drug Company and accept a thousand Irish pounds for each child that died. The dead children when then stuffed into a body bag and left as waste to be picked up at the end of the day. Nobody gave a fuck, who was to know, the children’s mother was herself working probably in the Laundry room, unaware her son died for a drug experiment, if the mother asked the Nuns about her boy, the mother was told that the son was sent to another school. If the Mother persisted in asking question about her son, she would be beaten and told to mine her own business. The Nuns word was absolute.

The Drug Company Doctors know best, said a satisfied Mother Superior of St. Patrick’s Mother and Baby Home, as the Drug Companies were paying cash to the happy Nuns. New altar linen and paint could now be brought for the Convent Chapel and fresh cut flowers for the new plaster statues of both the Infant Jesus and the Blessed Virgin Mary.

With the Drug Companies paying for the drug experiments in cash, and any, and all the physical rights to all of the dead babies bodies, thereafter, that way with cold hard cash, for both the drug experiments and cold dead babies, there were no need for official receipts or documents to come back and haunt both The Mother and Baby Homes and the Philanthropy of one of the great Drug Companies in the world, The Wellcome Trust.

The initial trials were carried out on thousands of defenceless Orphan Children of Mother and Baby Home in Ireland, some of the original batches of the alum-toxoid vaccine, which comprised of 9 per cent aluminium, caused severe reaction like fatal abscesses and hard lumps at the injection site. Subsequent many of the institutionalised children, had severe side-effects, including the immediate death of many of the Orphan Children, in many of The Mother and Baby Homes in Ireland, by the Drug Company, The Wellcome Trust. I have another medical document, Immunisation against diphtheria;- Date of 1st. Injection 26th. October 1954, 2nd. Injection 26th. January 1955, 3rd. injection 13th. September 1955. Result;- Negative.

It is a little know fact, that Doctors and Scientists of the Drug Company, The Wellcome Trust, secretly vaccinated more than 5,000 or more children in suspected illegal medical drug trials, in many of The Mother and Baby Homes in Ireland. Old medical records so far show that thousands of children and babies in Mother and Baby Homes throughout Ireland were given a one-shot diphtheria vaccine from international drugs giant Burroughs Wellcome. The downside of these secret vaccinations were that some of the vaccines given to the orphans in the Mother and Baby Homes and Orphanages had a deadly glitch in the 1950s It was discovered by medical researchers by pure accident who discovered that the polio vaccine distributed to the Mother and Baby Homes and Orphanages in Ireland in the 1950s and 1960s was infected with another virus called “Simian Virus 40.” SV-40 which was a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. This “Simian Virus 40.” was injected into tens of thousands of babies at the time this virus is causing brain and lung cancers to this very day.

Now, many years later. SV-40 has appeared in over 70% of all new cancer patients in Ireland, born during the 1950s and the 1960s and not just children from the Orphanages, but children born within Irish families nation-wide who also received this contaminated vaccine from the late 1950s to the era of the 1960s. Isolated fragments of this strain of SV-40 virus is present in human bones of many different cancers suffers now in their late 50s and 60s. More frightening researchers have determined that SV-40 virus can be transmitted sexually and through blood transfusions. Even more shocking, SV-40 has appeared in over 50% of all new cancer patients in Ireland, patients even too young to have received the contaminated vaccine being administered in the 50s and 60s

There is no evidence that consent was ever sought, nor any records of how many may children died or suffered debilitating side effects as a result. I can only go on my own medical records I have. Most of the secret drug experiments on orphans were carried out in the Mother and Baby Homes throughout Ireland, long before the vaccines were ever made available for commercial use in the United Kingdom.

More frightening researchers have determined that SV-40 virus can be transmitted sexually and through blood transfusions. Even more shocking, SV-40 has appeared in over 50% of all new cancer patients in Ireland, patients even too young to have received the contaminated vaccine being administered in the 50s and 60s. By the way HIV is a monkey hybrid virus also which was man made the same way as the Polio Virus, through the Rhesus monkey, viral fragments combine easily with other viruses to produce these hybrids called “chimeras.

These drug experiments were published in the most prestigious medical journals around the English speaking world, suggests that this type of human experimentation on institutionalised children in the Mother and Baby Homes in Ireland were largely accepted by medical practitioners and facilitated by Irish Catholic Authorities in charge of the Mother and Baby Homes, in Ireland. Another fact that no record of these drug experiments can be found in the files relating to the Department of Local Government and Public Health, in Ireland, or The Wellcome Trust Archives in London, or the Catholic Church Archives, In Ireland.

In actual fact, almost all of the files of the secret drug experiments on the institutionalised children and orphans in the Mother and Baby Homes, in Ireland, were conveniently destroyed, particularly by the Irish Catholic Church, in Ireland, which suggests that vaccine drug experiments, would have been very much acceptable to the Irish Government, in name at the time. The only people or Institutions who directly gained, financially were, the English Drug Company, The Welcome Trust and The Irish Catholic Church, through the Mother and Baby Homes.

What a fine sound business for the Nuns and a new source of blood money for the Holy Mother Church. Whatever happened to the Nuremberg Code after the Second World War The principles underlying scientific research, particularly that of consent. “Numerous international codes defined ethical standards for human experimentation, most notably the Nuremberg Code, the issue did not command any attention”. And then what about Catholic Ethos, O’ yes! it didn’t seem to apply to Whores or their spawns. A matter of particular interest to these trials is whether it was appropriate to use as subjects babies and children who were in institutional settings, particularly orphan children, so no need for consent. The real consent was bought with blood money.

The holy Nuns, who ran the Mother and Baby Homes, could easily be bought with thirty pieces of silver. The matter was never discussed in the available protocols at the time or for that matter any other time. In a little known secret Department of Health memorandum written in 1962 the Irish Government turned a blind eye, while the real Rulers in Ireland, Archbishop McQuaid and the clerics, struck their secret deals with the Drug Companies, General Medical Council and the other Irish Government.

Hapless children were forced into participating, enticed with chocolate sweets some of the sweets were laced with drugs and given to the children. The children did not willingly volunteer and no consent was ever sort or given for the procedures, there were nobody to ask, except the Nuns, and the Holy Nuns were not a problem. Instructions came from the Bishops and higher Church figures. So typically, the experiments resulted in death, trauma, disfigurement or permanent disability. Many Children were very sick with unusual high temperatures, and violent diarrhoea and vomit.

At St. Patrick’s Mother and Baby Home, and other Orphanages, under the direction of the Holy Nuns, selected Babies and Children who were subjected to various hazardous experiments that were designed to help Burroughs Wellcome, the drug company. A few of the Babies and Children died, unable to cope with the experiments. Medical staff under the direct supervision of Burroughs Wellcome Irish staff at the Orphanages, tested immunisation compounds and serums for the prevention and treatment of contagious diseases, including typhus, tuberculosis, typhoid fever, and infectious hepatitis. Not just the Babies or Children were the experiments tried on.

Sterilisation experiments were secretly used on selected Women in the wards of St. Patrick’s Mother and Baby Homes and other Mother and Baby Homes around Ireland. All the experiments were carried out, without the consent or acknowledgement of the women involved. Some of the women suffered weak-mindedness, schizophrenia, alcohol abuse, insanity, deafness, and physical deformities. Over a few years many of the selected women had been sterilised. The purpose of these experiments was to develop a method of sterilisation, which would be suitable for sterilising of the women with a minimum of time and effort.

These experiments were conducted by means of X-rays, and various untested drugs. Thousands of victims were sterilised. Aside from its experimentation, the intravenous injections of drugs, speculated in secret hushed tones, to contain iodine and silver nitrate, proved to be very successful, but had unwanted side effects such as vaginal bleeding, severe abdominal pain, and cervical cancer. Therefore, radiation treatment became the favoured choice of sterilisation.
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Specific amounts of exposure to radiation destroyed a person’s ability to produce ova or sperm. The radiation was administered through deception. Women were brought into a room and asked questions about their health and families, which took a few minutes. In this time, the radiation treatment was administered and, unknown to the women they were rendered completely sterile. Many suffered severe side effects, such as dizzy spells, vomiting and diarrhoea. Some of the women died later as a result of the experiments conducted by the Burroughs Wellcome, of England.

When a few of the women had died, tests were completed on their bodies to study the effects post mortem. Those who survived were often left mutilated, suffering permanent disability, weakened bodies, and mental distress. The issue of informed consent had previously been controversial in Irish Medical Circles, but the power and grip of the Catholic Church was too strong for many doctors and researchers to resist. Academics who depended on their jobs, through the Catholic Church, kept their mouth closed. The Catholic Church controlled all Professorships and research jobs within the educational institutions of Ireland.

The vast majority of the academic community supported the Church’s position completely. After all, these women were whores and prostitutes, and streetwalkers, who were infecting the streets of holy Ireland with untold diseases. The major excuse were the Women were prostitutes with syphilis, so their consent wasn’t needed. The women were not competent for this reason, nor consulted.

In another secret fact, unknown, after the Second World War, many Nazis escaped from a war ravished Europe and were helped by sympathisers in the Catholic Church, directed from the Vatican in Rome by The Red Cross and the Vatican officials, both helped thousands of Nazi war criminals and collaborators to escape after the second world war. Many of these fleeing Nazis were given safe passage through a natural Catholic Ireland, and later the Nazis were send on their way to new identities and life in other Catholic Countries in Latin America. A few Nazis medical staff and doctors made this route into Ireland a few stayed and made Ireland their home, a small few ended up working for the Drug Companies and researchers for Burroughs Wellcome.

I remember the Clinical Trials. My earliest memory was standing with a group of boys in a long line half naked with only my underpants on, as had all the other children in the line before and after me. There were what appeared to be four or five men and women in long white coats taking samples of blood and injecting children with a cocktail of colour liquid and examining the boys.

Also for days afterwards an unwrapped chocolate sweet was placed on the desk of a few of the children in my class, including myself.

I picked up the chocolate sweet, looked at it and eat it, but it tasted bitter, with a funny taste of liquid to its centre, I immediately spate the chocolate out and complained to the Sister Kevin that my chocolate sweet tasted funny, bitter, she came by my desk, picked the chocolate sweet up of the floor where I spate it out and gave me another one, “This one will be better, Patrick” I took the chocolate sweet of Sister Kevin with suspicion and put it into my hungry mouth, this time I swallowed the chocolate sweet, without biting and Sister Kevin seemed pleased, she returned to a large folio and made a few notes, looking all the time at me. I held the bitter chocolate, an dwhen she wasn’t looking I removed it and put it in my short trousers pocket to dispose of it when I next went to the toilet.

A few hours later a Nurse came into our class and picked out a few of the boys, including me, and examined us in another room. For the next few weeks this continued, the chocolate sweet, the bitterness taste, but I took the chocolate sweet in, in anyway, The Nurse examined us and more notes and probes. Life got on as normal, which is to say the routine of life growing up in an orphanage.

The births were so risky, at all the 200, Mother and Baby Homes, that expectant mothers were encouraged to confess their sins before they went into labour. A priest was always on standby, to both hear confessions and baptise the baby immediately, or before the baby or mother died, or if the baby was already dead in the mother’s womb, then the priest would throw only holy water on the thing, and the dead mother, mutter a few worthless prayers, the priest would return quickly to his whiskey.

Many of the new mothers were teenagers, when the mother went into labour, Untrained Farmer Nuns, would pull the baby’s head with such force, that in many cases, caused the real risk of delivering a premature baby, or that the mother, bled to death, with shock. With this induce labour, the risk of secondary infertility due to the increase of the risk of damage to the mother’s uterus caused by uterine rupture. Most labour was painful and prolonged, unnecessary in many cases.

Either the contractions were too long, and too strong and too close together, causing the baby to have difficulty in breathing. The untrained Nuns would not have known this, and really didn’t care. Once the baby was pulled out, like an animal on a farm, then the priest was called to do his job to baptise the baby or mother, for hell, the baby and mother were certainly weren’t going to heaven, why the baby reeked of mortal sins. No men were allowed, except a priest, who was not considered a man, but gods anointed. If the labour was difficult, the mother’s hair would be shaved or loosened and all hairpins and hairclips removed.

Cesarean births, were never performed, not even as a last resort. As the time of birth drew near, the mother would have to wait, there could be a few other births before her, and no medicines. The chosen untrained nun, would tie the umbilical cord and tie it at four fingers’ length. The delivery farm nun, would hand over the new born baby , if the baby survived, over to an assistant or assistants normally older women, who worked with the nuns, to bathed the child, then the infant would be wrapped in torn sheets, which would be changed every few days. The assistant women, then had the job of cleaning up the afterbirth, disposing of any dead babies into a sluice toilet and flush, but only after the blessing and departure of the priest. The Irish Catholic Church itself did not object to the miscarried fetus being flushed down the sluice, the Nuns who ran the Mother and Baby Homes didn’t want to know, they the nuns walked away, after all it was a problem of the older women to dispose of the unwanted fetus and not the holy nuns.

The other major problems were, fatal foetal abnormality, which the nuns didn’t understand, and didn’t care about, another was induced miscarriage, causing menstrual regulation, and regulation of a delayed, suspended menstruation infection called, sepsis, massive haemorrhage was very common, and injury to the internal organs, such as puncturing or tearing of the uterus, was all the rage. After all, without medical drugs, or forceps, here the ignorant, untrained medical practitioners called Nuns, willingly and readily preformed abortions on behalf of the Holy Mother Church.

Because of these untrained Nuns, a pandemic of infectious diseases, spread through the wards of the Mother and Baby Homes. Spreading endemic diseases that a few simple known drugs and basis hygiene at the time could have fixed. So the Good Nuns resorted to the only thing that could and would work, in their eyes was, Prayer. While Smallpox, Measles, Tuberculosis and basic Flu, and Whooping Cough, ravished the Women.
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The Holy Nuns realised that their Prayers wouldn’t work, according to the Holy Nuns, it couldn’t work because of the whores, had committed a mortal sin, and to the Good Nuns this was unforgivable in the eyes of God. The whores had to be punished and made to suffer. The Women that survived the wards, then had problems like loss of productivity and psychological damage, plus the rest of their lives, working to death, in Church Laundries and their children thrown into Industrial Schools to survive, many children were never to know their Mothers, brothers, sisters or any other family members. Owen Felix O’Neill

The Price of Death
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In 2011, it was revealed that another 400 dead babies, from St Patrick’s, Mother and Baby Home in Dublin, in which the Nuns who ran the Mother and Baby Home, The Daughters of Charity of St. Vincent de Paul, claim they didn’t know anything about, or were not sure what happened, but sold in a private sale the 400 dead baby bodies anyway, for £1,000 Irish punts a piece, at the time, to St Kevin’s Hospital. The 400 dead babies were sold to the nearby Hospital, St Kevin’s which was the largest university teaching hospital in Dublin at the time, now called St. James’s Hospital. The 400 dead babies from St. Patrick’s, Mother and Baby Home in Dublin, in reality the 400 babies were subjected to vaccine trials by established international medical companies, and this was what caused their deaths. The vaccine trials in Ireland were headed up by some of the country’s most eminent medical professionals. This is why the 400 baby bodies were sold to St. Kevin’s Hospital, Dublin. The Anatomical Committee of Irish Medical Schools said- that “today such practices would be unacceptable”and a joint statement from the Departments of Health and Children said they “deeply regretted” these “outdated practices”. The medical drug trial itself was published in the ‘British Medical Journal’ in 1962.The final paragraph of it reads:
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The hospital St Kevin’s was run by another group of Religious Nuns were the 400 dead babies were sold and used in dissections for medical students and medical universities of Ireland without the consent of their mothers, all this was kept secret or conveniently forgotten and any and all documentation was destroyed by the Holy Nuns. The Daughters of Charity of St. Vincent de Paul. The Nuns got away with lying about the sale for over 40 years, never acknowledging the evil deed of selling the 400 dead babies for profit. Even when the story came out in 2011, all they said was it was another era, and we have no documentation in our archives.In the year of 1942 alone, 57 babies were sent to UCD, 34 more to the Royal College of Surgeons and another 27 to Trinity College Dublin, 35 were sent to UCG, according to Official Irish Inspectors, but again many medical experts think that official figures given are far to low. The same Nuns, The Daughters of Charity of St. Vincent de Paul refused to keep to many records on their dead babies, but altered, or more conveniently disappeared, evidence and documentation, but a handsome profit was to be made by the greedy Nuns, who couldn’t feed the babies but instead sold the murdered and undernourished babies. Again I must quote Wittgenstein- “What we do not speak about we passover in silence”.Owen Felix O’Neill https://www.pressreader.com/ireland/irish-examiner/20170626/281616715375755

Births and Euthanasia/ Experiments

The births were so risky at the 200 Mother and Baby Homes, that expectant mothers were encouraged to confess their sins before they went into labour. A priest was always on standby, to both hear confessions and baptise the baby immediately in case the baby or mother died. If the baby were already dead in the mother’s womb, then the priest would only throw holy water on the thing (and perhaps on the dead mother too), mutter a few worthless prayers, then quickly return to his whiskey.

Many of the new mothers were teenagers. When the mother went into labour, untrained farm-raised nuns would pull on the baby’s head with such force that in many cases it caused the real risk of delivering a premature baby – or the mother bled to death or died with shock. With this brutal induced labour, the risk of future infertility increased due to uterine rupture. Most labour was painful and prolonged, unnecessarily so in many cases. Contractions might be too strong and too fast, causing the baby to have difficulty in breathing. The untrained nuns would not have known how to deal with this, and really didn’t care. Once the baby was pulled out, like an animal on a farm, then the priest was called to do his job of baptism although the baby and mother certainly weren’t going to heaven – why, even the baby reeked of mortal sin. No men were allowed to be present, except for priests, but then they were not considered to be men but rather gods anointed. If the labour was difficult, the mother’s hair would be shaved or loosened and all hairpins and hair-clips removed.

Caesarean births were never performed, not even as a last resort. As the time of birth drew near, the mother would have to wait; there could be a few other births happening – and no medicines. The untrained nun chosen to act as midwife would tie the umbilical cord at four fingers’ length. The delivery nun would hand over the new-born baby to an assistant, normally an older woman who worked with the nuns, to bathe then wrap the infant in torn sheets, which would be changed every few days. The assistant women had the job of cleaning up the afterbirth and flushing any dead babies into a sluice, but only after the blessing and departure of the priest. The Irish Catholic Church itself did not object to the miscarried foetus being flushed down the sluice. The nuns who ran the Mother and Baby Homes didn’t want to know; it was the assistants who performed the disposal of the unwanted foetus and not the holy nuns.

Other major problems which the nuns didn’t understand or care about were: fatal foetal abnormality; induced miscarriage causing menstrual disruption; infection (sepsis); massive haemorrhaging (very common) and injury to the internal organs such as puncturing or tearing of the uterus. Without drugs or forceps, the ignorant nuns, untrained as medical practitioners, willingly and readily preformed abortions on behalf of the Holy Mother Church.

Because of these careless, untrained nuns, a pandemic of infectious diseases spread through the wards of the Mother and Baby Homes. A few known drugs and basic hygiene could have prevented this. Smallpox, measles, tuberculosis, flu and whooping cough, ravished the women and babies over the decades that the Mother and Baby Homes operated.

So the good nuns resorted to the only thing that, in their eyes, could and would work – prayer. When the holy nuns realised that their prayers weren’t working, it could only be because the women were whores who had committed a mortal sin, which was unforgivable in the eyes of God. The whores had to be punished and made to suffer. The women that survived the wards consequently had problems like loss of fertility and psychological damage, plus for the rest of their lives, many were worked to death in the Church-run Magdalene Laundries. Their children, sinners too, were never to know their mothers, brothers, sisters, or any other family members and were thrown into Industrial Schools to survive as best they could in a regime of torture and deprivation.

Sterilisation experiments were secretly carried out on thousands of selected women in the wards of Mother and Baby Homes around Ireland. All the experiments were performed without the consent or acknowledgement of the women involved. As a result, many suffered weak-mindedness, schizophrenia, alcohol abuse, insanity, deafness, and physical deformities. The purpose of these experiments was to develop a method that would be suitable for sterilising with a minimum of time and effort.

The experiments were conducted by means of X-rays and various untested drugs. The intravenous injections of drugs, speculated in secret hushed tones to contain iodine and silver nitrate, proved to be very successful, but had unwanted side effects such as vaginal bleeding, severe abdominal pain, and cervical cancer. Radiation therefore became the favoured treatment for sterilisation because specific amounts of exposure to radiation destroy a person’s ability to produce ova or sperm. The radiation was administered through deception. Women were brought into a room and asked questions for a few minutes about their health and families. During this time, the radiation treatment was being clandestinely administered and, unknown to the women, they were being rendered completely sterile. Many suffered severe side effects, such as dizzy spells, vomiting and diarrhoea. Some of the women later died as a result of the experiments and the sterilisation procedure conducted by Wellcome Trust. When women died, tests were completed on their bodies to study the effects post mortem. Those who survived were often left mutilated, suffering permanent disability, weakened bodies, and mental distress.

The issue of informed consent had previously been controversial in Irish Medical Circles, but the power and grip of the Catholic Church was too strong for many doctors and researchers to resist. Academics who depended on their jobs through the patronage of the Catholic Church, kept their mouths shut; the Catholic Church controlled all professorships and research posts within the educational institutions of Ireland.

Even without the possibility of losing their positions, the vast majority of the academic community supported the Church’s position completely. After all these women were prostitutes who were infecting the streets of holy Ireland with untold diseases. Not only were the women whores, the major excuse was that they had syphilis and were therefore not competent, so there was no need for consultation or consent.

Another illegal, but nevertheless Church and State sanctioned, procedure carried out in the institutions for babies and children was euthanasia. The term “euthanasia”, (from the Greek for “good death”) is commonly ascribed the meaning of a painless death or mercy killing. Many of the children born with Down’s syndrome or suffering from chronic/terminal illnesses, were put to death in the many convents and Mother and Baby Homes, in a clandestine programme of systematic killings that was indirectly sanctioned by the Irish Catholic Church authorities. This “euthanasia” program targeted mentally and physically disabled babies as well as healthy children.

Previously unseen details of a medical trial by Glaxo in 1974 at a Cork mother and baby home have generated a whole new series of questions for the nuns and the companies involved. For almost two decades, the public has been drip-fed revelations about medical testing by British pharmaceutical companies on children in care in Ireland. These tests involved the trials of various vaccine combinations by predecessor companies of pharmaceutical giant GlaxoSmithKline (GSK) — Glaxo Laboratories and Burroughs Wellcome. These revelations generated more questions than answers — answers it is hoped the Mother and Baby Homes Commission can provide. However, it has now emerged that Glaxo Laboratories was also using other trial drug-products on children here — namely lactose and baby formulas. This occurred in 1974 in the Bessborough Mother and Baby Home in Cork and had never been made public. Once again, the revelation has generated lots of questions but few answers.​

A trial sheet obtained by the Irish Examiner reveals that Glaxo Laboratories carried out a “clinical acceptability and safety trial” of “Golden Ostermilk and Lactose”, while a separate trial sheet reveals a trial of “overseas milk powders. The “clinician responsible” for the tests was Eithne Conlon — a local Cork GP who worked with the institution for many years.
The trial sheets recorded a range of reactions to the products. These included vomiting (slight, moderate, severe, or none), excessive regurgitation, wind (slight, moderate, severe, or none), stools (locae, normal, or constipated) and stool colour (yellow, grass green, olive green, yellow green, no stools, meconium, changing). Other “abnormal conditions” were also noted. These included excessive crying, irritability, napkin rash, thrush, and others. The latter trial sheet was contained in the records of Breda Bonass, who had sought information on her medical history from Tusla under Freedom of Information.

The former only came to light when Ms Bonass sought further information from Tusla. However, this only confused matters further as the trial sheet for “Golden Ostermilk and Lactose” was found in the antenatal records of other women — and all contain identical details including patient numbers — something which the FOI officer told Ms Bonass was “perplexing”. “In the majority of cases where this record was present the record was glued to another copy of the same record [front to front] and details about the respective baby’s feeding schedules, types of formula given, reactions to feeds, etc., were hand written on this paper,” said the FOI officer.

“When I pried the two sheets apart I noticed that these trial sheets all contained the exact same patient and trial numbers and identifying details as the trial sheet located in your file.” Ms. Bonass went to the religious order which ran Bessborough — the Sisters of the Sacred Hearts of Jesus and Mary — and GSK looking answers. The nuns responded via their solicitors, telling her they no longer held the records nor had any access to them and that she should go to Tusla. GSK’s UK data protection section informed her that the data had been “destroyed” as the “retention period has already expired some years ago”. The Irish Examiner contacted GSK in an effort to get answers as to why this trial was carried out in Ireland, how many children it involved and if consent was sought.

It responded by saying it was “unable to locate any records relating to a 1974 study” but that it had located records relating to a trial from 1967.

“The assumption therefore would be that the 1974 study’s purpose was to compare current milk powder with a newer formulation. The records contain no names or information about the children involved,” said GSK in a statement.
It had no documentation to explain why Ireland was chosen as a location, but that the 1967 trial was also carried out in the UK, Kenya, Argentina, Malaysia, “and probably more”. With regard to the consent of mothers, GSK said that, due to the fact that it had no records, it could not confirm who gave consent but that its assumption was that it would have been “those Sisters running the homes as the legal guardians”.

Obtaining consent would been left to the doctor conducting the trial. The company said that, to the best of its knowledge, no financial remuneration would have been provided to the Order for allowing children in its care to be used for the trial. GSK said the identical sheets were probably blank forms or templates and that the information entered “appear to be codes, possibly relating to a spreadsheet collating all responses”.

It also confirmed that this was the first time it was made aware of this study and that it had not been asked to disclose it in any official capacity, “as this is clearly outside of the current Commission’s [Into Mother and Baby Homes] vaccines inquiry”. That, of course, is technically correct. The Commission is only tasked with examining vaccine trials carried out by GSK legacy companies. This latest revelation confirms that it wasn’t just vaccines that were being tested on children in care here. The involvement of Burroughs Wellcome and Glaxo Laboratories in trials on children in Mother and Baby Homes and other institutions is worth repeating. It’s been a long tale which saw a previous State inquiry —the Commission to Inquire into Child Abuse (CICA) in 2000 — try and fail to fully investigate the matter.

Before that inquiry was halted following a Supreme Court ruling in 2002, GSK had confirmed just three vaccine trials in the 1960s and 1970s involving more than 250 children. In 2011, in a response to an RTÉ investigation, it acknowledged a fourth trial but stated that this was the only other clinical trial sponsored by Wellcome using children in institutions in Ireland. However, in 2014, documents uncovered by Michael Dwyer of UCC’s School of History revealed a fifth trial of a measles vaccine on 34 children took place in 1965.

It was carried out by Irene Hillary and Patrick Meenan of UCD’s microbiology department and AJ Beale of Glaxo Laboratories. The UCD academics (both now deceased) were also involved in the first two vaccine trials also. Earlier that year, Dr. Dwyer also discovered evidence that Wellcome had carried out vaccine trials on more than 2,000 Irish children in 24 residential institutions between 1930 and 1935. Despite this, the Inter-Departmental Group on Mother and Baby Homes published in 2014 only referred to three vaccine trials. It also failed to mention a 1965 trial of a 5-in-1 vaccine carried out on Philip Delaney at Bessborough Mother and Baby Home in Cork. Questions around the involvement of British pharmaceutical companies in vaccine trials in Ireland have been popping up in the media for almost three decades now.

They first hit the headlines in the 1990s, but it wasn’t until 1997 that then health minister Brian Lenihan gave an undertaking that the matter would be examined. This resulted in the Kiely Report in 2000, by Jim Kiely, chief medical officer of the Department of Health, which confirmed three trials had been conducted on behalf of the pharmaceutical company the Wellcome Foundation. The institutions involved were Wellcome Laboratories in Britain, the Department of Medical Microbiology in UCD, and the Eastern Health Board. The first trial took place between December 1960 and November 1961 in four Mother and Baby Homes — St Patrick’s on the Navan Road in Dublin (14 children), Bessborough in Cork (25 children), Castlepollard in Westmeath (six children), and Dunboyne (nine children).

Four children from Stamullen baby home in Meath were also used for this trial. The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diphtheria, whooping cough, tetanus, and polio.

The second trial involved 69 children from St Anne’s Industrial School in Booterstown in Dublin being administered an intranasal rubella vaccine. A further 53 children from the wider community in Kilcullen in Westmeath were also used in this trial. The first two trials were carried out by Prof Hillary and Prof Meenan from the department of Microbiology in UCD, as well as other doctors. The third trial involved 53 children in a number of residential institutions in Dublin including St Patrick’s Home, Madonna House, Bird’s Nest, and Boheenaburna.

A total of 65 children living at home in Dublin also received the vaccine. The aim of the third trial was to compare commercially available batches of the 3-in-1 vaccines — Trivax and Trivax D — with that of equivalent vaccines prepared for the trial. There is no published paper or report of this trial, but the Eastern Health Board was aware it was being conducted. Dr. Kiely’s report in 2000 concluded that, given the conditions, which the vaccines sought to counter, the decision to conduct the trials was “acceptable and reasonable”. However, Dr. Kiely said there was a lack of documentation available to clarify whether consent was either obtained or sought from the parents of the children or the managers of the institutions.

However, an entry in the 1962 British Medical Journal concerning the first trial seems to confirm that parental consent was not sought.

“We are indebted to the medical officers in charge of the children’s homes for permission to carry out this investigation on infants under their care,” it wrote. Responding to the Kiely Report in 2000, Prof Hillary said it was her “invariable practice at the time to obtain consent of the competent authority”, be it the mother, the manager, or the medical officer.

However, no record of written consent has been acknowledged. The religious orders that ran the homes involved in the trials have also denied that they authorised any clinical trials. Of the victims of the vaccine trials who have located their natural mothers, all mothers have said they were not asked for their permission. In 2000, then minister for children Micheál Martin admitted the Kiely report was “incomplete” and raised “as many questions as it answered”. However, despite this, Mr. Martin reassured the Dáil that the trials appeared to have had no medically negative consequences for any of the children involved. In an effort to deal with the matter, the Government decided to extend the terms of reference of CICA. This was done despite objections that the trials could not adequately be dealt with by an inquiry looking primarily into physical and sexual abuse.

The ‘Vaccines Module’ of CICA began investigating in early 2002.

It obtained documentation from GSK — the successor of Wellcome — and identified the names and addresses of some of those involved in the trials.

It also sought records from a range of religious orders that were caring for the children used in the trials.

In November of last year, the Irish Examiner revealed that the files of vaccine trial victims from Bessborough involved in the 1960/61 4-in-1 vaccine were altered just weeks after the CICA sought discovery of records from the Sisters of the Sacred Hearts of Jesus and Mary.

The document listing the changes opens with: “8.8.02 checked the 20 files.” This is immediately followed by: “9.8.02 made the changes.”

The changes made to files Nos 5, 8, 11, 12, and 15-20 are then detailed.

The changes include:

• The alteration of discharge dates of mothers (by a period of one year and two years):
• The changing of discharge dates of children;
• The changing of admission dates of mothers;
• The alteration of the age of a mother (by two years);
• The alteration of dates of adoption;
• The changing of baptism dates and location of baptism; • The insertion of certain named locations and information into admission books.

In a series of statements, the order said it wished to “categorically state that no documents were altered”.

“In your recent correspondence, you are suggesting that something illegal or inappropriate had occurred in regard to the documents to which you refer. This is entirely untrue; and we will continue to deal directly with the official commission on all such matters,” said a statement.

This document listing the changes was discovered in the Bessborough archive handed over to the HSE by the nuns in 2011.

It wasn’t discovered until 2016 — some 13 years after CICA’s investigation into the vaccine trials was suspended.
This occurred after the probe was hit with a Supreme Court ruling, which upheld Prof Meenan’s challenge against a High Court order directing him to give evidence before the inquiry.

The court also criticised the decision to ask the commission to examine the vaccine trials in the first place, stating they had “only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the commission was established to inquire”. Mr. Justice Hardiman stated that Prof Meenan’s involvement in vaccine trials related only to one trial in 1960/61 and that the issue of the “reputational damage” associated with being involved with a commission primarily looking at sexual abuse had to be considered. Following this, Prof Hillary challenged the Government’s order directing an investigation into the vaccine trials and when the Government declined to appeal this decision, the work of the Vaccines Module ceased in November 2003. However, at the time, many people believed there were far more than three trials carried out by Wellcome here.

The Third Interim Report from CICA in December 2003 confirmed as much when it stated that the documentation it received from GSK “disclosed a considerable amount of information in relation to other vaccine trials conducted in the State”.

When RTÉ’s Prime Time asked the pharmaceutical giant about this statement in 2011, it confirmed a fourth trial had taken place in 1965. This trial involved giving differing doses of the measles vaccine to 12 babies aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in County Tipperary. GSK stated that this fourth trial was the only other clinical trial sponsored by Burroughs Wellcome using children in institutions in Ireland. Then, in 2014, the Irish Examiner revealed a fifth trial also occurred during this period. An article in The Lancet medical journal in August 1965, discovered by Dr. Dwyer confirms that Glaxo Laboratories Ltd carried out another measles vaccine trial on 34 children aged between eight months and just over two years. The trial was carried out by Prof Hillary and Prof Meenan and AJ Beale of Glaxo Laboratories. It is also the first trial, which confirms Glaxo Laboratories involvement in a vaccine trial.

The report does not mention an institution. However, it makes reference to the fact that the reaction to the vaccine was monitored by “the adults looking after the children”. It also says examinations were done on the children from day six to 14 at the same time — 6pm — indicating the children were in a group setting.

However, in response, GSK disagreed that these references amounted to evidence that the trial was carried out on children in care. The pharmaceutical giant pointed out that, in other papers by the same investigator, it was stated explicitly that the study was carried out on children in care. GSK said if it had any evidence that this trial was carried out on children in care, it would have handed it over to the CICA at the time.

So, three years on, we now know that it wasn’t just vaccines that were being tested on children in Ireland’s Mother and Baby Homes.

Now, we know that clinical acceptability and safety trials of lactose, Golden Ostermilk and “overseas baby powders” were being tried in at least one Mother and Baby Home. Were religious orders benefiting financially by allowing children in their care to be involved in such trials? Was the consent of mothers obtained, or was it even sought?
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Medical miracles are complicated, but Catholic Church Miracles are never complicated. Catholic Church miracles are downright fraud but, if it is a great miracle, the Catholic Church will hijack it to make money. There will be no testing or verification by scientists – only the Catholic Church itself can do that. It is a poor Roman Catholic Church in Europe that does not boast several relics of Saints and wooden crosses. Owen Felix O’Neill

The Scandal of the Illegal Vaccine Drug Trials

Over the course of many decades the Irish Catholic Church – in collusion with Drug Companies and the Irish Government – conducted a series of medical experiments on vulnerable babies, orphan children and their mothers in the Mother and Baby Homes, Industrial Schools and Orphanages that they controlled and ran. In most cases, these experiments resulted in death, disfigurement, or permanent disability. Especially disturbing, was the fact that the drugs being tested were known at the time to have serious side effects and the safety of children and women was knowingly being put at risk.Several of the illegal drug testings on the vulnerable babies and orphan children in the Mother and Baby Home, Industrial Schools and Orphanages in Ireland, reported that the children and babies suffered constant side effects such as unknown sores and rashes, violent vomiting and violent spasms, with sudden involuntary muscular contractions and convulsive movements. Haematemesis, which is the vomiting of blood was very common, and the panicked Nuns that ran the Mother and Baby Home and Orphanages in Ireland didn’t know how to react as the babies and children died in front of them. In one secret medical report, drug company researchers reported a “disturbing” higher death rate among the children and babies who took higher doses of these experimental drugs.Many researchers were unable to determine a safe and effective dosage that they were giving to the vulnerable babies and orphan children. In many cases the child’s rectum was the route used for the illegal drug medications with other fluids, and resulted in rectal bleeding because the rectum’s blood vessels couldn’t absorb the quantity of untried and untested drugs being pumped into the child. The illegal drug experiments also disturbed the child’s circulatory system and their developing organs.

The Medical drug Companies who carried out the illegal experiments told the gullible Nuns that there was minimal ​or no risk ​to the child, and that the child would directly benefit because of the drugs given. The Irish Catholic Church was paid a handsome price, as were the greedy Nuns. The murderous cabal then counted out for the duplicitous Church their “thirty pieces of blood soaked silver”. That’s all they considered Jesus to be worth, but an orphan child from a Mother and Baby Home, Industrial School or Orphanage, was worth more dead than alive – a thousand times that. The Irish Catholic Church leaders used their thirty pieces of bloody criminal silver to buy and sell more vulnerable babies and orphan children, acquire more buildings, churches and fields, paralleling the story in the Bible of Matthew 27;6-10, except in the fields that the Church bought, they furrowed the fields with the blood and remains of the thousands of murdered babies and children that they couldn’t sell back to the Medical Drug Companies, who experimented and killed them in the first place. The Irish Catholic Church speaks mere words. With worthless oaths they make covenants and judgment sprouts like poisonous weeds in the furrows of their field.

The vulnerable babies and orphan children in the Mother and Baby Home, Industrial Schools and Orphanages in Ireland, were usually involuntarily placed in artificial environments, usually in special rooms within the harsh Institutions for the duration of the illegal drug experiments. The child’s behaviour was monitored by both the researchers and the willing Nuns.The drug experiments caused great distress and abnormal behaviours among the vulnerable babies and orphan children, most of whom were strapped into their cots or beds. All the children were in a heightened state of distress, much like the phenomenon of contagious anxiety. Cortisone levels rose in the children watching another child being restrained for blood collection. Blood pressure and heart rates would be elevated in children watching other children being prodded and poked, and fed tubes of running liquid.

Routine research procedures, such as catching a screaming child and removing him or her from their cot beds, in addition to the experimental procedures, did cause significant and prolonged elevations in vulnerable babies and orphan children​’s​ stress markers. These stress-related changes in physiological parameters caused by the researchers’ procedures and the child’s environment can and did, have significant effects on test results. Stressed out vulnerable babies and orphan children, for example, developed chronic inflammatory conditions and intestinal leakage. Because of the stressful conditions, some of the children and babies had strokes.

​Many of the experimental medical drugs failed in the clinical trials causing confusion among the researchers, with different readings which added variables that confounded the data the researchers were gathering. Under closer scrutiny, it is not difficult to surmise why more than 3,750 of these potential therapies failed. The Medical Drug Companies also introduced or reintroduced the diseases in the children, so as to observe the effect that the different experimental drug reactions had on the child which was very important to the researchers. Many of the experimental drugs given to the children contributed to a high failure rate in the new drugs being developed; the downside was the painful, slow death of the child.

Usually, when a child was found wanting, or the medical drug failed, various reasons were proffered by the researchers to explain to the Drug Company what went wrong with the experiments, citing poor methodology, inexperienced Nuns and poorly trained drug company researchers​, with the addition, their lack ​of ​​knowledge ​of preexisting disease and medications ​already administered ​​to the children. The wrong gender or age of the child were also factors that certainly required consideration. Recognition of each potential difference between different children’s diseases motivated renewed efforts to eliminate these differences and were worked out by the Nuns and Drug Company Researchers in seeking their next batch of guinea pig children. So diseases and conditions were reintroduced to the new batch of vulnerable babies and orphan children and the illegal medical experiments continued.

Many of the children were injected with new, untried immunomodulatory drugs. Within minutes of receiving the experimental new drugs, many vulnerable babies and orphan children suffered a severe adverse reaction resulting in life-threatening problems which led to catastrophic systemic organ failure. Some medical drugs used were designed to fail by attacking the vulnerable children’s immune systems instead. The stone-faced researchers watched the stressed-out child struggling in pain while the Nuns who were observing, prayed, but never once intervened to help the struggling child. Many of the vulnerable babies and orphan children were given or underwent repeat-dose toxicity and given many times the normal dose for a few consecutive weeks. All of course went devastatingly wrong.

​Many babies and orphan children who survived were permanently scarred and harmed and many would die. Imprecise results from the experiments resulted in clinical trials of biologically faulty and harmful substances being used thereby exposing the children to unnecessary risk and even death. The children that have survived, now adults, have been significantly impacted in many ways with unexplained illnesses, in addition none had medical histories to call upon, so unusual or unexplained cancers developed, stressed heart problems, with leaky valves, like bicuspid aortic valves, and much more. Almost all documentations has conveniently disappeared, both from the Religious Run Institutions and the Drug Companies that carried out the illegal medical drug trails. The complicit Irish Government now claims that they were misled by the safety and efficacy profile of the new drugs based on the experiments carried out in many of Ireland’s Mother and Baby Homes, Industrial Schools and Orphanages.

Who would allow a person or organisation to administer painful and experimental medical drugs to vulnerable Babies and Children in Orphanages​? ​​​Who but the compliant Irish Catholic Church – and they did it purely for the money. The Catholic Church has always been thought of as the caretakers of mankind’s soul, while the medical profession was considered the healer of human health. The trust of both was​​​, and is,​ sacred. But something went radically wrong, both lost their morals and ethics, their personal and professional compass for right and wrong, by allowing untested and illegal medical drugs to be used​ on vulnerable Babies, their Mothers and orphan Children in Religious Orphanages, in Ireland. The Irish Catholic Church’s evil is perceived as the dualistic antagonistic opposite of good, in which evil, itself prevail and good was defeated.

The Irish Catholic Church’s part in these illegal medical experiments, is egregious, outrageous, and shocking. The Irish Catholic Church violated the trust placed in them by humanity. The most painful truth is for the most part the Irish Catholic Church committed crimes against Humanity and lived a life, and lie, unlike their victims.

​A​s a society​, we have to confront the dark past and the reality that both the Irish Catholic Church and the Medical Drug Companies are guilty of the premeditated murder of vulnerable Babies and Children in Irish Orphanages. Medical and illegal drugs used on these vulnerable children, masquerading as research, resulted in the deaths of defenceless Babies and Children in the many religious run Institutions of Ireland. Why do we as a society have great difficulty condemning both the Medical Drug Companies and the Irish Catholic Church as evil? My question is this: Is it ever appropriate to use research as morally repugnant as that which was extracted from the vulnerable Babies and Children in Irish Orphanages for six decades and openly encouraged by the Irish Catholic Church, purely for money? If so, under what circumstances? We as a society need to comprehend fully the magnitude of this issue – the death of probably thousands of vulnerable Babies and Children in Irish Orphanages in these drug experiments – with both moral clarity and brutal honesty. When is the enormous and unspeakable suffering of those vulnerable Babies and Children who perished in (and those who survived) these horrendous Religious Run Institutions ever acceptable.

Let’s pull no punches here. The Medical Drug Companies performed insidious illegal medical experiments upon helpless, defenceless Babies and Children, in Irish Orphanages for six decades.These acts of barbarity were characterised by several shocking features​: defenceless children were forced against their will to become human guinea pigs in very dangerous studies; who were selected solely if their mothers or parents were dead; and all the innocent children were enticed and bribed with sweets to endure incredible suffering, mutilation, and indescribable pain. Sadly the illegal medical drug experiments were often deliberately designed to terminate in a fatal outcome. We know that the medical drug experiments were conducted in an unethical manner, so can the research results be considered scientifically reliable? And yes – the Medical Companies used the data collected from the experiments to make vast profits at the expense of the hapless Orphans.

To this day the Medical Drug Company have the dat​a ​​but refuse to release ​it. In recent years, there has been a sharp debate regarding the scientific validity of these illegal medical drug trials and whether research gathered from the lethal experiments on the defenceless Babies and Children of Ireland, can be used in any way by the scientific community. The answer is that all the data gathered was used to enrich the drug companies who made hundreds of millions of dollars on the backs of these defenceless Babies and Children in Irish Orphanages with the willing and active participation of the reprehensible Irish Catholic Church, who also reaped tens of millions for themselves at the expense of the most vulnerable in Irish society – orphan children in the wretched Irish Orphanages, controlled by the Church and run by the Religious Orders. Remember that thousands of Babies and Children died from malnutrition in the Mother and Baby Homes in Ireland, with thousands more, suffering from constant malnutrition and many more suffering from anorexia. Again let’s be absolutely clear, the despicable Irish Catholic Church and the odious Medical Drug Companies are and were morally tainted and soaked with the blood of its orphan victims, the Babies, their Mothers, and Children.

What good derives from this evil?, I ask myself. What kind of “good” could be salvaged from the illegal medical drug experiments and the resulting deaths and disabilities performed on these defenceless Babies and Children in Irish Orphanages, who society dumped into these hellholes of religious run Institutions? What was the benefit of these wicked experiments​? T​he many deaths of hapless children -​ is that acceptable? C​an it be ever be justified? The Irish Catholic Church thinks so, and the Drug Companies claim that society in general benefited​. Of course they also claim that the children benefited, but in reality many children died, and many more Survivors wander around aimlessly, confused, and with known and unknown medical problems to sort out. They have no answers to their many questions stemming from their wretched childhoods at the mercy of both the Religious Orders that ran the Institutions and the Medical Drug Companies that used them as unwilling guinea pigs.
​
Since the dead orphan babies and children can no longer represent themselves, I will always speak out for them and, indeed, for myself, for I too was the subject of a few medical drug experiments in both St. Patrick’s on the Navan Road, Dublin and St. Philomena’s Home Stillorgan County Dublin. From the age of 18 months I was experimented on and, as a result, I couldn’t walk for the first four years of my life and I still bear scars, each as big as a euro coin, on my left arm, the other scars are invisible, and are many, my personal childhood traumas and my mental scars, I will carry, like a dead weight cross, to my final resting place, my peaceful grave. Owen Felix O’Neill

https://www.theguardian.com/world/2004/apr/04/usa.highereducation
GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as ‘laboratory animals’ Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed. British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children’s Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities.

In all, at least 14 infants enrolled in clinical trials for the drug died during the testing. Eligibility criteria for study were age between 6 and 16 weeks, and “free of any known or suspected health problems”, therefore, healthy infants. It is estimated that more than 19,000 babies have received at least one dose of Synflorix (The COMPAS trial is still ongoing, but not recruiting anymore).

In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, federal prosecutors announced Monday. The agreement also includes civil penalties for improper marketing of a half-dozen other drugs.

This briefing paper provides an overview of known examples of unethical clinical trials. It was prepared by SOMO, in collaboration with Wemos, and is based on secondary sources. Although the focus is on developing countries, it also includes a few cases from the US and Europe. By providing such an overview, the paper aims to illustrate problems in the ethical conduct of clinical trials. It does not provide an analysis of clinical trials in general or of the scale of ethical violations. Indeed, the scale of the problem is unknown, because it cannot be estimated how many unethical clinical trials escape public attention and therefore remain unnoticed.

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Defence force personnel left with debilitating psychological effects from taking anti-malarial drugs are looking forward to the release of a long-anticipated report into the use of two separate medications.

Anti-malarial products mefloquine and tafenoquine have been prescribed for Australian defence personnel — as well as general civilians — for many years.

While mefloquine was registered with the Therapeutic Goods Administration as early as 1988, with tens of millions of prescriptions globally, recent years have shone a light on the drug’s potential side-effects.

A months-long federal government inquiry into the use of the two drugs, and any “adverse health effects” of their use, is due to report this week after being twice delayed.

The Department of Defence outlines that most symptoms are “minor”, and can include sleep problems, vivid dreams, anxiety and depression. In around 10 percent of cases, the department said, users can experience dizziness or headaches.

In one percent of cases, the department noted, side-effects can include “agitation, restlessness, mood swings, panic attacks, confusion, hallucinations, aggression, psychosis and suicidal ideation”, as well as balance problems and seizures.

Much attention has been paid to the use of the drugs by defence force personnel around the world, including in the US and UK, with countless members sharing personal stories with journalists.

More than 1300 ADF members were prescribed mefloquine in a trial in Timor Leste in the early 2000s, while others — including retired army officer Stuart McCarthy — were given the drug, and another called tafenoquine, in other overseas missions to developing countries to combat malaria.

(Getty Images)

“I had a lot of chronic health issues that I could never really get to the bottom of. I was given tefenoquine in Bougainville in 1999, and I didn’t really think much of it connected to the subsequent health problems I had,” McCarthy told 10 daily.

“Even though I was given a very high dose during the trial, and the purpose was to eradicate malaria, I still got malaria regardless.”

McCarthy said he also later developed a range of serious psychological conditions, including depression, and other “subtle but noticeable” issues like vertigo and what he classed as general “cognitive decline”.

He claimed up to 3000 people may have been affected by these drugs, saying he had spoken to “hundreds” of families and was aware of some suicides allegedly linked to the use of the anti-malarial drugs.

“The evidence now is these drugs can cause a permanent brain injury. There’s a very distinctive set of symptoms including psychiatric ones, like depression, anxiety, and neurological symptoms,” he told 10 daily.

“The drug trial I was involved in, tafenoquine, my experience was there was very little if any info on side effects, other than you might have some gastro for a few days. There was no mention of possibility of brain damage.”

(Getty Images)

Around 140 Australian personnel were prescribed mefloquine between 2010 and 2016, according to the defence department.

“A Senate report will be released today on the use of anti-malarial drugs, which has had direct input from veterans throughout Australia and I look forward to reading the findings,” Veterans Affairs minister Darren Chester told 10 daily on Tuesday.

“I am focussed on putting veterans and their families first and delivering the essential services they rely on, with more than $11 billion provided each year.”

The Senate inquiry into ‘Use of the Quinoline anti-malarial drugs Mefloquine and Tafenoquine in the Australian Defence Force’ attracted nearly 140 submissions.

Those who used the drugs have complained the drug trials were incorrectly administered, and that the government has not provided appropriate access to health or support services to deal with ongoing side-effects.

“There is clear, extensive evidence of the harmful effects of mefloquine and tafenoquine, including lasting impact on many hundreds of Australian quinoline veterans and their families,” the Quinoline Veterans and Families Association (QVFA) said in its submission.

“Despite claims by Commonwealth officials that adequate help is available, the government has consistently denied the fact that these drugs are able to cause permanent brain damage resulting in widespread chronic neuropsychiatric illness and in some cases suicide.”

“There is a compelling need for the Commonwealth to implement a comprehensive program of outreach, rehabilitation and research, led by experts in ABI and clinical neurotoxicology.”

(Getty Images)

In its own submission, the Department of Defence defended the use of mefloquine, saying it was not commonly used and only as a “third-line” treatment when people could not use two other more popular treatments.

But it acknowledged side-effects had been experienced by some personnel.

“Defence has always acknowledged that mefloquine can cause side effects, including neuropsychiatric problems, while individuals are taking the drug,” the department wrote.

“Generally, symptoms will disappear when the individual stops taking the drug but they can persist for some time afterwards due to the drug’s long half-life of two to four weeks. Defence also acknowledges that neuropsychiatric side effects have been known to continue and become long term in a small number of individuals.”

The Senate report is due to be delivered this week.

McCarthy acknowledged concerns raised by himself and others affected by the drugs had been well-received by federal officials, but said the government needed to take action.

“There needs to be a royal commission,” he told 10 daily.

“Most important, we need dedicated outreach and rehab programs for people affected by these drugs. We want the government to set up a program of referrals, so anyone with these symptoms can be referred to the appropriate medical specialist, and also appropriate social support.”

Asserting a Chicago federal appeals panel wrongly invalidated a jury’s verdict, attorneys for the widow of a Chicago lawyer who committed suicide after taking the generic version of the antidepressant drug Paxil, have asked the U.S. Supreme Court to throw out the appellate ruling and order more proceedings on whether pharmaceutical company GlaxoSmithKline should be made to pay for allegedly not revising their drug’s warning label to reflect an increased risk of suicide.

On Dec. 19, attorneys for Wendy Dolin filed a petition with the U.S. Supreme Court, asking the nation’s high court to take up their appeal of the decision from the U.S. Seventh Circuit Court of Appeals in Chicago, which had found a federal jury was wrong to order drugmaker GSK to pay Dolin $3 million. In that decision, the appellate judges had essentially found GSK could not be held liable for the content of the warning label on its medication, because those labels were controlled by the U.S. Food and Drug Administration.

“The Seventh Circuit’s decision creates a world where a drug manufacturer is permitted under the First Amendment to promote its drug for non-FDA approved indications, … but a drug manufacturer is prohibited from issuing warnings concerning life threatening risks associated with its drug,” Dolin’s attorneys wrote in their petition.

The petition was filed about four months after a panel of three Seventh Circuit judges threw out the verdict in favor of Dolin, widow of lawyer Stewart Dolin, who killed himself in 2010 in a downtown Chicago transit station. Wendy Dolin alleged her husband was taking paroxetine, the generic version of GSK’s Paxil. She alleged the drug’s label, which was written by GSK and is identical for the name brand and generic versions, did not adequately warn the drug could increase the risk of suicide. Dolin alleged GSK knew of the alleged increased risk, yet chose not to revise the warning label.

Bijan Esfandiari Baum Hedlund Aristei & Goldman P.C.

GSK, however, said it tried several times to secure approval from the FDA to revise the label, but the FDA declined.

After years of proceedings in federal district court in Chicago, a jury found in favor of Dolin at trial. GSK appealed, and the Seventh Circuit overturned the verdict.

In the appellate decision, the judges, led by Circuit Judge David Hamilton, found GSK had asked the FDA four times to change the labels, but the FDA had ordered GSK to use standard language the FDA approved for paroxetine and other antidepressants. This showed GSK had no control over the labels, Hamilton said.

In their petition to the Supreme Court, however, Dolin’s lawyers said this finding represented a misreading of the case. They asserted the FDA had not disallowed the revisions, but rather had directed GSK to publish suicide risk warnings as a supplemental warning, known as a Changes Being Effected, or CBE, provision.

Dolin’s attorneys painted the Seventh Circuit ruling as “unreasonable,” as it came despite contrary findings from “nine jurors and two distinguished district court judges reviewing the same facts” who “found that GSK was not prohibited from issuing stronger warnings.”

“There is no evidence the FDA ever rejected a paroxetine-specific adult suicide warning,” Dolin’s lawyers claimed. “The FDA’s invitation to GSK to use the CBE (which GSK could use unilaterally without the FDA’s invitation) to issue a paroxetine-specific adult suicidality warning in a place within the label that is outside the class labeling section can hardly be considered or interpreted as a rejection of a paroxetine-specific adult suicide warning.

“…It is akin to being invited to dance but construing that invitation as clear evidence of rejection.”

Dolin’s lawyers noted the Supreme Court is scheduled to hear arguments in a similar case, Merck v Albrecht.

In that case, the U.S. Third Circuit Court of Appeals came down on the question opposite the Seventh Circuit. In their decision, Dolin’s lawyers assert, the Third Circuit judges determined such labeling questions were appropriate for a jury, and “a reasonable juror could conclude that ‘the ball was in (drugmaker) Merck’s court’ to submit a revised CBE for the correct enhanced warning.”

Dolin’s lawyers asked the Supreme Court to delay action on their petition until resolving the Albrecht case. But after Albrecht, the lawyers asked the high court to vacate the Seventh Circuit decision and remand the case for new proceedings.

The petition was filed by attorneys Bijan Esfandiari, of the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles, and David E. Rapoport and Mathew S. Sims, of the Rapoport Law Offices P.C., of Chicago.

GSK has been represented by attorney Lisa Blatt, of Arnold & Porter Kaye Scholer, of Washington, D.C., and by the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta.

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It seems that Glaxo CEO, Emma Walmsley, has perhaps quit her job at Glaxo to become a stand up comic? (as evidenced by the screen-shots).

However, there’s nothing funny about Glaxo’s 3 Billion Dollar Fine with the US department of justice (How many people were killed from dodgy off label prescribing from fraudulent behavior for this fine alone?)

There’s nothing funny either about concealing data, which results in the deaths or disablement of unsuspecting patients.

Nothing humorous in any of Glaxo’s crimes.

There is however, something very funny about the images of Emma Walmsley sprouting on about trust, particularly when you consider Glaxo are still currently under investigation by the serious fraud office in the UK, and also in light of Thomas Reilly’s case against them (currently pending).

It seems along with Glaxo’s ethics, its humanity and its morals, its entire manufacturing system is also not fit for purpose too (how many people are unknowingly being harmed from that fact alone?). How many dodgy meds end up maiming unsuspecting patients from Glaxo’s long list of product recalls?

“…..A senior whistleblower at GlaxoSmithKline is suing the drugs giant over claims his warnings about allegedly dangerous botched IT projects were hushed up by his superiors who eventually ended his 16-year career at the company.

Thomas Reilly worked around the world designing, installing and troubleshooting major IT projects at GSK production plants and at its UK and US data centres.

He claims he warned for years of serious issues in IT systems in many countries that caused numerous factory shutdowns.

Yet, in a lawsuit filed against the firm in the US, he says his concerns were not properly acted upon by his superiors in Britain. In one case, he says his warnings about a Latin American plant were covered up by his manager for fear of alerting auditor PricewaterhouseCoopers….”

From weight gain to postpartum depression, Meghan Boggs has been sharing her struggles, fears, failures and successes on Instagram for quite some time. Five days ago, she shared another. Only this time, it wasn’t her story to tell— it was her sister’s.

Meet my sister, Tilly. Her #iam1in5 story is one that has changed her, our family, and so many people around the world. Tilly has been on medication since she was 15 years old. During her second pregnancy, she was told that it was safe to continue taking her antidepressants (Paxil). She then discovered at an ultrasound just four weeks before her due date that Adrian, her son, had several heart defects. Adrian had open heart surgery at just 8 days old. Tilly found out just a few months later that this was all caused by the antidepressants she was on during her pregnancy and sued the company. Adrian was one of the very first cases, and she won. The labels were then changed to reflect the dangers of taking them while pregnant. But even though she won the case, she was left with a child who would never live a normal life. She was left with the guilt that came with her decision to continue the medication even though she was told it was safe. . It’s now been 14 years since she had Adrian, and he’s had 5 open heart surgeries, 3 pacemaker changers, countless heart catheterizations and will eventually need a heart transplant. She is the definition of strength and I have always looked up to her because she is an unbelievable mother. She is also 1 in 5, but even through all that she has been through, she has always done whatever it takes to be the best mother to all three of her children. She is a warrior and I am so thankful she agreed to share her story. * To read her full story and her advice for anyone who is struggling to cope with being off medication during their pregnancy, head over to my blog. And watch my stories to see photos of Adrian throughout his journey. ♥️ * Disclaimer: This post is not meant to provide medical advice. Always consult your doctor about any questions about your health, medications, and pregnancy. You have options. Let your voice be heard.

“Meet my sister, Tilly,” she wrote. “Her #iam1in5 story is one that has changed her, our family, and so many people around the world.”

Boggs’ sister, Matilda (Tilly) Berrelez, has been on antidepressants since she was 15 years old. She was 21 in 2003 when she found out she was pregnant with her second child.

At the time, Berrelez (then Vasquez) was told it was safe to continue taking Paxil—an SSRI (selective serotonin reuptake inhibitors) drug she’d been taking to treat depression and anxiety. So, she did as she was told and continued taking the medication, unaware of any risk to her unborn child.

Four weeks prior to her due date, however, an ultrasound revealed that her baby had several heart defects.

Adrian Vasquez, born April 19, 2004, was only 8 days old when he underwent his first heart surgery. Five months later, news broke that taking Paxil during early pregnancy could cause heart defects, lung defects, clubfeet and cranial defects in newborns.

Paxil during early pregnancy could cause heart defects, lung defects, clubfeet and cranial defects in newborns.

Boggs told Mom.me that Adrian’s case was “the very first one to go against a pharmaceutical company.” In fact, she added, “CNN covered this and came out to our house to film.”

After winning the case against GlaxoSmithKline—the makers of Paxil—Boggs said companies began changing their labels to reflect the risks and dangers of taking SSRI drugs while pregnant.

“But even though she won the case, she was left with a child who would never live a normal life. She was left with the guilt that came with her decision to continue the medication even though she was told it was safe.”

In a full story on Meg Boggs, Berrelez (now 36), recalls the moment she learned her son was in trouble. After waiting nearly 45 minutes for a technician to finish taking an ultrasound, she asked if there was something wrong.

“She stopped the ultrasound, looked me in the eyes for a split second, looked down, then told me she would be right back with me and left the room,” she wrote. A few minutes later, she returned with the doctor, who said, “I’m sorry to tell you this, honey, but there is something wrong with your baby’s heart.”

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Pandemrix and narcolepsy

Where is the outrage? GlaxoSmithKline suppressed clear danger signals from vaccination with Pandemrix. The result, to begin with, was the suffering of a large number of children and adolescents who developed narcolepsy. Peter Doshi is to be commended for dispassionate reporting of the facts, but I am frustrated by his cool rhetoric in the face of what I believe are acts of greed and cruelty.

The facts reported by Doshi are new, but the pattern of behavior is not. The manufacturers and their professional surrogates are past masters at doing research that shows short-term vaccine efficacy but that does not reveal serious adverse effects. They always end up saying, as in this case, that “there is no proof of a causal association.” Such behavior might be forgiven if influenza vaccines were real lifesavers, but we still do not know if they have done more good than harm in the long run. I am not alone in making this assertion.

Not long ago Gaffney and Lexchin said that US and Canadian pharmaceutical systems, “…are dysfunctional. Costs are exorbitant, commercial goals distort drug development, misleading promotion fosters misuse, and medications are too often unaffordable for patients.” (BMJ 2018;361:k1039) Much the same can be said for the development and promotion of vaccines in the last 10-15 years.

I get frustrated and angry about the promotion of some drugs and vaccines, but I am saved from despair by the efforts of professionals like Doshi and his colleagues who keep plugging away at the facts.

Allan S. Cunningham

Competing interests: No competing interests

24 September 2018

Allan S. Cunningham

Retired pediatrician

Cooperstown NY 13326, USA

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Those who keep a finely tuned eye on GSK won’t fail to notice that they are involved in a lot of product recalls (see here) . Of course the Reilly versus GSK lawsuit is obviously related to GSK’s manufacturing (or lack of good manufacturing) and this malfunctioning system leads to substandard drugs being released. GSK were fined for their Cidra debacle, but how many more Cidra’s are there out there? who knows? Perhaps we will find out through another lawsuit- the blue-cross blue shield one?

Date: 4 OCT 2018 Recall: # 18-026

Out of abundance of caution, Glaxo Smith Kline announced a voluntary recall of Prevacid 24 Hr capsules due to possible microbial contamination. The Exchange currently sells the 14ct. capsules.

Hazard: Healthy people can develop mild illnesses from contact with some forms of microbial contamination, however; serious infections may occur in people in the hospital and/or with weakened immune systems.

Incidents/Injuries: To date, no illnesses have been reported in connection with this problem. This recall is being conductined out of abundance of caution.

Description: The following product is affected.

Remedy: Customers who purchased the product are encouraged to return it to the store where it was purchased for a full refund.

Consumer Contact: Customers who have additional questions or concerns should contact the GSK Customer Service team at 1-800-743-4014, Option 5 for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

Sold at: Worldwide Exchange facilities, Online E-commerce and other retailers.

Consumer Contact:

This letter is to inform you that GSK Consumer Healthcare is conducting a voluntary retail level recall of:

Prevacid® 24HR Capsules, 15 mg lansoprazole (14, 28, and 42 counts)

UCC: Please refer to Attachment 1 for full list of impacted UCC codes

UPC: Please refer to Attachment 1 for full list of impacted UPC codes

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

In keeping with our commitment to quality, GSK Consumer Healthcare has made the precautionary decision to voluntarily recall all Prevacid® 24HR Capsules lots within expiry at the retail distribution level. This decision is based on microbiological out of specification results obtained for one lot of Prevacid® 24HR Capsules that remains within GSK control and has not been distributed. Although all lots on the market and within expiry have met all release test specifications, current available data cannot exclude potential impact to released product. There is no evidence of a consumer safety concern based on a completed medical assessment that concludes the use of, or exposure to, the affected product is not likely to cause adverse health consequence.

Please note that product is being recalled at the retail level. This is not a consumer level recall.

Affected lots (within expiry) were manufactured between October 8th, 2015, and March 26, 2018, and distributed in the timeframe between January 7th, 2016 and September 2nd, 2018.

GSK Consumer Healthcare is committed to providing the highest quality products to our customers. We regret any inconvenience this recall may cause and appreciate your cooperation.

If you have any questions, please contact our GSK Customer Service team at 1-800-743-4014, Option “5”, for PREVACID® 24HR 15 mg Lansoprazole Capsules, Recall Event Number 134PREV18.

A leading medical journal has warned that serious safety “indicators” were raised over the swine flu vaccine Pandemrix in 2009 – almost two years before the vaccine was finally suspended from use in Ireland.

‘The British Medical Journal’ published a major investigation into the use of the drug across Europe where it is now linked to cases of narcolepsy or severe sleep disorders in children.

Last night, one solicitor acting for Irish children who developed narcolepsy said it was “a scandal” families have been fighting for justice for seven years while the State was aware of such data.

Support group Sufferers of Unique Narcolepsy Disorder (SOUND) said the report was “shocking and utterly appalling.”

The British report relies on multiple European investigations and ongoing legal actions over the drug, manufactured by GlaxoSmithKline (GSK).

Last August, a major Irish Independent investigation revealed some children received a double dose of Pandemrix when stocks of the vaccine were used from January 2011 amid fears there would be a shortfall for the normal winter flu jab.

Solicitor: Michael Boylan is handling many of the narcolepsy cases. Photo: Collins Courts

Thousands of children received a single vaccine dose in 2009/2010 at the height of swine flu scare.

But the 2011 re-issue was almost two years after research data showed indicators that Pandemrix had a far higher rate of adverse incidents than other comparable vaccines.

Pandemrix was re-issued to GPs nationwide in 2011 despite the fact major studies were already under way in Sweden and Finland into potential links with narcolepsy.

Re-issued in Ireland on January 7, 2011, the vaccine was recalled on March 28, 2011 when both studies indicated there was a likely link to narcolepsy.

The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines.

It calculated Pandemrix had a 500pc greater rate of “adverse events” reported than another swine flu vaccine.

In Ireland, Pandemrix was only made available before it had completed its testing protocols because the Government had offered GSK a full indemnity.

Almost 100 families are now suing the Government, Health Service Executive and GSK.

Many of the narcolepsy cases are being handled by solicitors Michael Boylan and Gillian O’Connor.

“The fact that the general public were not made aware by the Minister for Health or the HSE that Pandemrix was untested prior to or even during the vaccination programme as adverse data emerged is one of the reasons why we have now served the State defendants with claims for aggravated and exemplary damages,” Ms O’Connor said.

“It is a scandal and totally unacceptable that our clients have had to fight tooth and nail for accountability and appropriate redress for the dreadful injuries caused for the past seven years given that this information has been within the defendants knowledge all this time.”

GSK declined to comment given ongoing legal action.

SOUND said the group was “shocked and appalled” at the report.

“These revelations now present very serious questions for the State, the HSE and GSK as to what exactly happened with Pandemrix.